What is the optimal dosage of valganciclovir as preemptive therapy for CMV infection in allogeneic hematopoietic SCT?

摘要

CMV infection is a common complication after allogeneic hematopoietic SCT (HSCT). Valganciclovir hydrochloride (VGC) is an orally available prodrug of ganciclovir (GCV; L-Valyl ester), that was first approved for the prevention of CMV disease in high-risk (donor positive, recipient negative) solid organ transplants (1800mg/day as a standard dose) and for the treatment of CMV retinitis in HIV positive patients. We read with interest the paper by Ayala et al. about the safety and efficacy of VGC preemptive therapy for CMV infection in allogeneic HSCT. However, the optimal dosage of the drug in this setting has not been established yet. Previous studies in HIV-infected patients and liver transplant recipients have shown that a VCG dose of 900mg/day results in an area under the plasma concentration-time curve (AUC) for GCV similar to that of i.v. GCV 5 mg/Kg/day. A recent study by Einsele et al. showed that exposure to GCV after the administration of 1800mg/day of VGC as a preemptive therapy in HSCT is significantly higher compared with i.v. GCV 10 mg/Kg/day. Similarly, Winston et al.6 reported that GCV exposure after 900 mg of VGC orally was non-inferior to that of i.v. GCV (5 mg/Kg) in HSCT recipients with gastrointestinal GVHD.